MAUDE Adverse Event Report: SORIN GROUP ITALIA XTRA BOWL SET 125ML; AUTOTRANSFUSION SYSTEM, PRODUCT CODE: CAC

Model Number N/A

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the xtra disposable.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis.It was also reported that the patient experienced hypotension but there was no injury.A report against the equipment was filed under medwatch number 9611109-2015-00347.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis.It was also reported that the patient experienced hypotension but there was no injury.

Manufacturer Narrative

Expiration date: 01/2018.Device manufacture date: 02/2015.Sorin group (b)(4) manufactures the xtra disposable.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that samples taken from blood processed using an xtra autotransfusion device showed hemolysis.It was also reported that the patient experienced hypotension but there was no injury.A report against the equipment was filed under medwatch number 9611109-2015-00347.The device was not returned to sorin group for investigation, but an investigation was performed by the customer.Follow-up communication with the customer has revealed that the reported issue was unrelated to the xtra autotransfusion device and the disposable.A pathologist analyzed the cell saver blood and was able to rule out any issues with the blood.After a full investigation, the facility concluded that the issue experienced by the patient was not related to cell salvage.The patient was on angiotensin-converting enzyme (ace) inhibitors at the time of the event, which are widely used as treatment for hypertension.Hypotension is a potential side effect of the use of these drugs.A review of the dhr was unable to identify any concessions, deviations or non-conformities relevant to the reported failure.No trends was identified for this type of issue; this is the first report of potential correlation between hypotension and the use of the xtra machine and disposables.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.Investigation performed by customer.

• Brand Name: XTRA BOWL SET 125ML
• Type of Device: AUTOTRANSFUSION SYSTEM, PRODUCT CODE: CAC
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo), 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola, 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5125240
• MDR Text Key: 27419626
• Report Number: 9680841-2015-00415
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 04251
• Device Lot Number: 1502030133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1